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European Biopharmaceutical Review

Patenting Biosimilars

In the world of pharmaceuticals, innovator companies seek to develop products containing novel therapeutic agents such as compounds and biologics. This requires an extensive R&D outlay, both for pharmaceutical products, which will ultimately reach the market, and those that fall at one of the many hurdles along the way. Such companies hope to recoup some of these costs through patent revenue, and obtaining patent protection for an innovative therapeutic agent is thus central to the strategy for developing a product.

For a new therapeutic agent, perhaps the most valuable form of patent protection available is a product claim broadly covering the agent per se as well as related agents considered to possess corresponding therapeutic activity. This will allow the innovator company to prevent a third party from making, using, selling, or importing the company’s pharmaceutical product. Depending on the scope of the patent claims, such a patent may also allow the innovator company to prevent a third party undertaking these activities in relation to agents containing only arbitrary modifications. Other valuable forms of patent protection include claims relating to methods of obtaining or manufacturing the agent, formulations of the agent for administration, and combination products including the agent and another pharmaceutical product. In the US, obtaining claims relating to a method of treating a certain condition using the agent is also possible. Such claims are not permitted in Europe as they are considered to unduly restrict medical professionals from treating patients using patented pharmaceuticals. However, claims drafted as medical use claims, ie “compound X for use in a method of treating disease Y”, are permitted and provide a similar scope of protection.

Innovative therapeutic agents must be extensively tested before they are given market approval. This can lead to a substantial delay in bringing the product to market. To compensate for this perceived loss of patent term, patentees can apply for a Supplementary Protection Certificate (SPC) in Europe, although similar provisions are not available in the US. An SPC is a national right that extends the duration of a patent insofar as it relates to an approved pharmaceutical product. The extension is granted for a maximum of five years, with an additional six-month extension available if paediatric testing has been conducted. SPCs can be extremely valuable as they are valid at the end of a patent’s lifespan when the pharmaceutical product will be at its most lucrative and generics companies will be keen to launch biosimilar products. For this reason, an extension of patent term of only a few days can be worth millions of pounds in revenue to the innovator company.

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Jennifer O’Farrell is a Partner in the biotechnology and life sciences group at Boult Wade Tennant. Jennifer has more than a decade’s experience of obtaining, attacking, and defending patents in the biotech field. She has extensive experience prosecuting patent applications before the EPO, as well as attacking and defending patents during opposition proceedings before the EPO, managing clients’ international patent portfolios, advising on filing strategies, and prosecuting patent applications before the UK Intellectual Property Office. Jennifer has been extensively involved in the filing of SPC applications throughout Europe.
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Jennifer O'Farrell
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